Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine

NCT ID: NCT00826475

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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Patients suffering from migraine will be randomly allocated to one of two different behavioral interventions:

* mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health.
* into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigators will measure the frequency and intensity of migraine attacks before during and after the intervention as well as secondary variables on quality of life and psychological functioning. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

Detailed Description

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Sixty patients suffering from migraine will be randomly allocated to one of two different behavioral interventions: (i) mindfulness based stress reduction (MBSR) an eight week intervention program based different meditation \& yoga techniques and teaching information regarding the relationship between stress and health. or (ii) into an active control group teaching three times within eight weeks relaxation techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine. The investigator will measure the frequency and intensity of migraine attacks before during and after the intervention by headache diaries as well as secondary variables on pain sensation, psychological well being, generic quality of life, pain regulation, pain acceptance, mindfulness, compliance and satisfaction with the intervention. The hypothesis is that patients allocated to the MBSR intervention will reduce the frequency of their migraine attacks compared to the active control group and compared to their own baseline.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness

Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction MBSR

Intervention Type BEHAVIORAL

Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills

Psychoeducation

Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Interventions

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Mindfulness Based Stress Reduction MBSR

Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills

Intervention Type BEHAVIORAL

Psychoeducation

Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* migraine for at least 6 months
* commandment of German language
* 3-8 migraine attacks per month
* willingness to participate in a behavioral intervention and to conduct the daily homework
* if patients take a drug as prophylaxis for migraine no change of drug for at least three months and no change of dose for at least one month prior to enrollment

Exclusion Criteria

* psychiatric disorders at the time of enrollment
* addiction
* participation in other trials
* prior experience with mbsr
* migraine related to the ovary cycle
* abuse of acute medication for migraine
* other psychological disorders which impair the communication and interaction with the patient
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Institute of Environmental Health Sciences, University Medical Center Freiburg

Locations

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University Medical Center Freiburg

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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423/08

Identifier Type: -

Identifier Source: org_study_id

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